Regulatory/GMP Compliance, Europe

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

The agency detailed its 2015 achievements in an annual report.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

The agency extends the indication of the drug in combination with bendamustine.

The agency holds a workshop to strengthen collaboration with healthcare providers.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.

The agency prepares a plan to implement new packaging safety features.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

On Dec. 8, 2015, Sandoz, the generic pharmaceutical’s division of Novartis, announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for a biosimilar to Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor.

Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

The new executive director of the European Medicines Agency begins appointment.

The European agency presents guidelines for conducting post-authorization efficacy studies.

Virtual pilot programs examine scenarios that may occur while implementing serialization requirements for the US Drug Supply Chain Security Act.

The PRIME program is a drug development scheme to enable accelerated assessment of medications for conditions with unmet need.

Melanoma treatment, Imlygic, received a positive opinion from CHMP, and several other products received extension of indications.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.